This is a Phase I-II study designed to investigate nimotuzumab (TheraCIM h-R3) in combination with external radiation in patients with non-small cell lung cancer. The purpose of the Phase I portion of the study is to evaluate the safety and feasibility of the administration of nimotuzumab with palliative radiation in patients who are unsuitable for radical therapy and to select the optimal dose for the Phase II component of the study. The primary objective for the Phase II portion of the study is to examine the efficacy of this combination treatment. The Phase I component of this study has been completed. The Phase II is now closed to recruitment.
This is a randomized, double blind, multicenter Phase II study with Phase I lead-in. Patients enrolled in this study will receive external radiotherapy with or without nimotuzumab (TheraCIM h-R3). The objective of the Phase I component of the study is to evaluate the safety and feasibility of the administration of nimotuzumab with palliative radiation in patients who are unsuitable for radical therapy (curative intent chemoradiation) and to select the optimal biologically effective dose (BED) for Phase II component of the study. In the Phase II component, overall survival, local and systemic response rates and quality of life will be evaluated inpatients treated with nimotuzumab in combination with palliative radiation vs. radiation alone. The Phase I component of this study has been completed. The Phase II is now closed to recruitment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
52
Radiotherapy for first 2 weeks, 10 daily fractions of 30Gy 2 additional fractions to be added if desirable
weekly dose until disease progression
Florida Cancer Institute - New Hope
New Port Richey, Florida, United States
Tom Baker Cancer Center
Calgary, Alberta, Canada
Cancer Centre for the Southern Interior
Kelowna, British Columbia, Canada
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada
London Regional Cancer Center
London, Ontario, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Thunderbay Regional hospital Center
Thunderbay, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Centre Hospitalier de L'Universite de Montreal - Hôpital Notre Dame
Montreal, Quebec, Canada
...and 3 more locations
Phase II: Overall survival
Time frame: Every 8 weeks until disease progression
Phase I: Biologically effective dose
Time frame: 2.5 Years
Phase II: Overall response rate
Time frame: Every 8 weeks until disease progression
Local response rate
Time frame: Every 8 weeks until disease progression
Overall clinical benefit
Time frame: Every 8 weeks until disease progression
Local clinical benefit
Time frame: Every 8 weeks until disease progression
Time to progression
Time frame: Every 8 weeks until disease progression
Time to local progression
Time frame: Every 8 weeks until disease progression
Progression-free survival
Time frame: 1 year
Phase II: Quality of life
Time frame: At week 4, week 8, every 2 months thereafter
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